Job Title: TMF Operations Associate
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Role Overview:
The TMF Operations Associate plays a critical role in ensuring the efficient processing, maintenance, and archiving of essential documents. This position requires strong organizational skills, attention to detail, and excellent communication abilities.
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Key Responsibilities:
* Process and review Trial Master File (TMF) documents for complex studies or Sponsor portfolios in electronic and hard copy formats.
* Perform periodic TMF Quality Control checks to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
* Collaborate with various Electronic Document Management and eTMF Systems to review, classify, and process Essential Documents.
* Communicate directly with RMC Leads to report trends and issues relevant to the TMF.
* Escalate any TMF Quality issues to RMC Leads in a timely manner.
* Provide administrative support for RMC Leads, including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and trackers).
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Required Skills and Qualifications:
* Proficiency in using an electronic document repository or eTMF and document recognition skills.
* Strong interpersonal skills in fast-paced, deadline-oriented environments.
* Sound judgment and ability to identify decisions requiring supervisory approval.
* Proficiency in Microsoft Word and Excel.
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Your Background:
* University Degree preferred (Life Science desirable)
* 1-2 years of relevant experience.
* Knowledge of working within highly regulated industries (desirable).